FDA Launches Online Genomics Platform to Advance Precision Medicine

In December, the Food and Drug Administration (FDA) launched its precisionFDA web platform, a cloud-based research and development portal that will enable scientists from industry, academia, and government to collaborate to improve the quality and accuracy of genomic testing.

FDA developed this platform to support President Obama’s Precision Medicine Initiative, with a specific goal of trying to determine whether a database of reference material could be useful in evaluating the validity of conclusions generated by next-generation sequencing tests.

Both individuals and organizations participating in precisionFDA can conduct genome analysis and comparison against reference genomes such as the so-called “Genome in the Bottle,” a reference sample of DNA for validating human genome sequences developed by the National Institute of Standards and Technology. Users can then publish their results to obtain feedback from the rest of the precisionFDA community. In addition, participants can access and share analysis pipelines and bioinformatics tools.

“We’re confident that employing such a collaborative approach to DNA data will yield important advances in our understanding of this fast-growing scientific field, information that will ultimately be used to develop new diagnostics, treatments, and even cures for patients,” wrote Taha A. Kass-Hout, MD, director of FDA’s Office of Health Informatics, and Elaine Johanson, precisionFDA project manager, in an FDA Voice blog post.

Currently, the platform is in its beta phase, and FDA plans in the coming months to work with users to improve its usability, openness, and transparency. More information is available at precision.fda.gov.

Cepheid Receives FDA Clearance, CLIA Waiver for Xpert Flu+RSV Xpress Test

The Food and Drug Administra­tion has granted Cepheid 510(k) clearance and CLIA waiver for the Xpert Flu+RSV Xpress test for use on the GeneXpert Xpress system. The Xpress system comprised of a single module and a tablet computer with an ATM-like interface designed specifically for the CLIA waived environment. Xpert Flu+RSV Xpress is the first PCR panel test to achieve CLIA waiver, and the first in a series of reference-quality molecular tests that Cepheid intends to deliver to the point-of-care market over the next several years. It uses the same design as Cepheid’s lab-based Flu/RSV XC test and includes high-level multiplexing, redundant target segments, and extended coverage for human and avian influenza strains. Both tests detect and differentiate between influenza A, influenza B, and respiratory syncytial virus (RSV) in about 1 hour.

Bio-Rad Gets FDA Nod for D-100 System for A1c Testing

The Food and Drug Adminis­tra­tion has cleared Bio-Rad Laboratories’ D-100 system for hemoglobin A1c testing, which is designed to monitor the long-term blood glucose control of individuals with diabetes, to aid in the diagnosis of diabetes, and to help identify those who may be at risk for developing the disease. The D-100 is a fully automated instrument utilizing high-­performance liquid chromatography technology and is intended to meet the needs of medium- and high-volume­ clinical labs with greater throughput and a simplified workflow. The system is also designed to deliver rapid results without sacrificing the ability to detect hemoglobin variants, which can interfere with the interpretation of test results. Earlier in 2015, Bio-Rad obtained CE marking and released the D-100 system in Europe, Canada, and several countries in the Asia-Pacific region.

FDA Clears Luminex Respiratory Pathogen Panel

Luminex has received Food and Drug Administration (FDA) clearance for its NxTAG Respiratory Pathogen panel, which detects 20 clinically relevant viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae and Mycoplasma pneumonia. The panel enables labora­tories to detect all 20 pathogens simultaneously in a single closed-tube system. Extracted samples can be added directly to pre-plated, lyophilized reagents, after which the tubes are sealed and ready for closed-tube amplification and subsequent detection using the Luminex Magpix instrument. The NxTAG Respiratory Pathogen panel’s format also scales to accommodate changes in throughput needed to respond to seasonal changes in demand, especially during flu season. The tube-strip design offers laboratories the flexibility to manage variable sample demand by processing a single sample or up to as many as 96 samples per run, without wasting consumables or reagents. Total turnaround time for the panel is about 3 hours for 96 samples, excluding extraction.

FDA Approves Roche HIV Test

Roche has earned Food and Drug Administration (FDA) approval for the cobas HIV-1 viral load test for use on the cobas 6800 and cobas 8800 systems. Based on Roche’s dual-target technology, this assay enables labs to amplify and detect simultaneously two separate regions of the HIV-1 genome that are not subject to selective drug pressure. It is part of the next generation of Roche viral load assays, which are designed to help clinicians make informed decisions for HIV-1 patients undergoing antiretroviral therapy. In addition to the new HIV-1 assay, Roche offers the FDA-approved cobas HBV and cobas HCV viral load tests on the cobas 6800/8800 systems. These fully integrated, automated solutions provide up to 96 results in less than 3.5 hours, and a total of 384 results for the cobas 6800 system and 960 results for the cobas 8800 system in an 8-hour shift. Both make it possible for labs to perform up to three tests in the same run with no pre-sorting required.